Personnel in the Central Service Room (CSR) or the Sterile Processing Department (SPD) of hospitals are commonly charged with the responsibility of packaging surgical supplies into various types of sterilization packaging systems and sterilizing the systems to ensure that the sterility of the packaged contents is maintained from sterilization to the point of reuse. Several activities are involved in the task of preparing medical supplies (e.g., devices, accessories, components, etc.) that are contained in the sterilization packaging system for delivery to the operating room, cardiac catheterization lab, emergency room, labor and delivery room, intensive care unit, pediatric care unit, specialized burn care units, and other surgical or medical units.
Much of the surgical instruments and supplies used in the operating room are reusable. These supplies typically include such things as clamps, scalpel blade handles, retractors, forceps, scissors, surgeon's towels, basins, and the like. All of these supplies must be collected after each procedure, decontaminated, washed, placed in a sterilization packaging system, and sterilized before they can be used again in another procedure. The sterilization packaging systems used must be of the size and shape to accommodate the items to be sterilized, must be compatible with and withstand the physical conditions of the sterilization process, and must be capable of maintaining the sterility of their contents post-sterilization.
Typical means of sterilizing instruments include, among others, autoclaving with pre-vacuum and gravity steam, exposure to ethylene oxide gas, and exposure to hydrogen peroxide plasma or vaporized hydrogen peroxide. After the packaging system and its contents have been sterilized, the sterilization package system typically is stored until it is needed for a surgical or medical intervention procedure, at which time it is transported to the operating room, cardiac catheterization lab, emergency room, labor and delivery room, intensive care unit, pediatric care unit, specialized burn care units, or any other surgical or medical unit, or it can be stored in an environmentally controlled room until it is needed by the medical staff for utilization in a surgical or medical intervention procedure.
Common sterilization packaging systems include sealable pouches, sterilization wraps, and rigid containers. Although each of these systems has some advantage compared to other systems, each of these typical packaging systems also has drawbacks. As an example, using a sterilization wrap to package items to be sterilized in a certain prescribed manner will permit the entry of sterilizing vapor/gas or other medium to sterilize the contents of the wrapped package while denying the ingress of contaminants such as bacteria and other infection causing materials or their vehicles after sterilization. As such, sterilization wraps generally provide a consistent barrier against the ingress of contaminants. However, during storage and transfer to the operating room, the wrapped package may be handled several different times; each time the wrapped package is handled, there is a potential that the sterile nature of the package contents can be compromised, e.g., by a tear, cut, or other breach of the wrapping material, which can occur due to over handling or careless manipulation of the wrapped package.
As another example, sterilization containers—such as, e.g., a metal box and a rigid top or lid that closes the metal box—also can permit the entry of sterilizing medium while denying the ingress of contaminants after sterilization. Unlike sterilization wraps, rigid sterilization containers usually avoid tears, cuts, and the like that can compromise the sterilized contents of the container. However, typical rigid sterilization containers are complex packaging systems, including several parts that must be precisely assembled to prevent compromising the contents of the container after sterilization. Further, some parts of the sterilization container assembly are prone to warping, denting, and breakage, as well as mismatching, loss, and/or other damage. Additionally, the gasketing could experience viscoelastic changes over time due to thermo-mechanical or physical stress associated with repeated sterilization, disinfection, and/or mechanical washing. Thus, even if the parts of the container can be assembled, damaged or worn parts can prevent proper assembly or closure of the sterilization container and thereby allow the ingress of contaminants after sterilization.
In particular, the gasket that is used to seal the container lid to the container base is typically integrated into the container lid, which is reusable, where such reusability can lead to the formation defects in the gasket. For instance, over time the gasket can experience wear and tear, which results in a decrease in its compressibility and, as a result, its sealing performance. Further, deformations in the lid can cause the gasket to be move out of optimal placement with the base, creating a gap in the seal between the lid and the base. In addition, the number of sterilization cycles to which a gasket is subjected is not easily tracked and there is no indication for when a gasket needs to be replaced.
Moreover, considering the filter and gasket design specifically, in some designs, proper filter placement cannot be confirmed once the container is closed. In addition, most rigid containers have complicated assemblies where the filters and gaskets are held in place by retention plates with various locking mechanisms, which complicates the assembly and lead to variation in how a filter is sealed, which increases the risk for bacterial ingress. Furthermore, the gaskets and locking mechanisms for the retention plate can degrade over time, which can also increase the potential for bacterial ingress.
Consequently, there is a need for a sterilization packaging system that overcomes the shortcomings of known packaging systems. In particular, a sterilization packaging system that includes a one-time or known limited use filter and gasket assembly would be beneficial to avoid the risk of not having a proper seal that can occur when a gasket has been reused an unknown number of times. Additionally, a sterilization packaging system that indicates to the user that a proper seal between the lid and base has been achieved would be advantageous. Moreover, a sterilization packaging system that provides a continuous sealing interface, that eliminates the need for retention plates, and that eliminates multiple interfaces associated with the base, lid, gasket, and filter would also be useful.